A Phase I, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec (T-VEC) injected into liver tumors
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چکیده
Introduction T-VEC, an intralesionally-delivered oncolytic immunotherapy, is a herpes simplex virus-1 engineered to selectively replicate in tumors and stimulate an antitumor immune response through expression of GMCSF. T-VEC has the ability to lyse various cancer cell types in vitro[1]. A Phase III study of T-VEC injected into skin, subcutaneous, or lymph node tumors versus subcutaneous GM-CSF in advanced melanoma demonstrated improved durable response rate for T-VEC, with regression of both injected and uninjected lesions[2]. To further explore if different types of cancers and locations might be treatable with T-VEC, this Phase I study evaluates whether primary and metastatic liver tumors may be safely and effectively injected with T-VEC.
منابع مشابه
A Phase I/III, multicenter, open-label trial of talimogene laherparepvec (T-VEC) in combination with pembrolizumab for the treatment of unresected, stage IIIb-IV melanoma (MASTERKEY-265)
A Phase I/III, multicenter, open-label trial of talimogene laherparepvec (T-VEC) in combination with pembrolizumab for the treatment of unresected, stage IIIb-IV melanoma (MASTERKEY-265) Georgina V Long, Reinhard Dummer, Antoni Ribas, Igor Puzanov, Olivier Michielin, Ari VanderWalde, Robert HI Andtbacka, Jonathan Cebon, Eugenio Fernandez, Josep Malvehy, Anthony J Olszanski, Thomas F Gajewski, J...
متن کاملPhase 1 results of a phase 1b/2, multicenter, open-label trial to evaluate safety and efficacy of talimogene laherparepvec (T-VEC) and ipilimumab (ipi) vs ipi alone in previously untreated, unresected stage IIIB-IV melanoma
Methods In this 2-part study (NCT01740297), phase 1b evaluated the safety of T-VEC in combination with ipi as assessed by the incidence of dose-limiting toxicities (DLTs) at full doses of both agents. For 6 to 9 patients (pts) evaluable for DLT, approximately 18 pts were to be enrolled in phase 1b. DLTs were defined as any grade (gr) ≥ 3 immune-related adverse event (AE) or gr ≥ 4 AE of any eti...
متن کاملSystemic versus local responses in melanoma patients treated with talimogene laherparepvec from a multi-institutional phase II study.
BACKGROUND We previously reported that talimogene laherparepvec, an oncolytic herpes virus encoding granulocyte-macrophage colony-stimulating factor (GM-CSF), resulted in an objective response rate of 26 % in patients with advanced melanoma in a phase II clinical trial. The response of individual lesions, however, was not reported. Since talimogene laherparepvec is thought to mediate anti-tumor...
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Background T-VEC is an HSV-1-derived oncolytic immunotherapy designed to selectively replicate within tumors, produce GM-CSF and enhance systemic antitumor immune responses. In OPTiM (NCT00769704), a randomized Phase III trial of intralesional T-VEC vs subcutaneous GM-CSF for unresected stage IIIB-IV melanoma, TVEC significantly improved DR rate (partial response or complete response lasting co...
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Background Talimogene laherparepvec (T-VEC) is an injectable modified oncolytic herpes simplex virus type-1 (HSV-1) hypothesized to be efficacious by at least two complimentary mechanisms of action: a) direct oncolysis of the injected tumor and b) elicitation of a systemic antitumor immune response against non-injected lesions and metastases. The purpose of this study was to test that hypothesi...
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